Senior Quality & Project Engineer

Senior Quality & Project EngineerDublin, OH - Onsite / Hybrid (Local Candidates Preferred)Full-Time | Medical Device | Robotics + Clinical Innovation We are developing a breakthrough robotic medical device designed to improve patient outcomes and transform how clinicians deliver care. We are seeking a Senior Quality & Project Engineer to build and own our quality system while driving cross-functional project execution across engineering, clinical, and regulatory workstreams. This is a high-impact, hybrid role blending Quality Engineering and Project Management, ideal for someone who thrives in fast-paced early-stage environments, is energized by ownership, and wants to help bring a first-of-its-kind device to market. What You'll DoQuality Engineering (Primary Long-Term Focus) Lead the development, implementation, and ongoing management of an electronic Quality Management System (eQMS) Ensure compliance with ISO 13485, current FDA regulations and guidance, and conformity to relevant recognized standards such as IEC 62304 and IEC 62366-1 Maintain core QMS elements including DHF, DMR/DHR, CAPA, Risk Management Files, document control, and change control Evaluate the current QMS platform and lead migration to an industry-recognized eQMS if appropriate Partner closely with clinical leadership to support readiness for upcoming testing, verification/validation, and future clinical trials Serve as the internal SME for quality requirements and help the team interpret standards as the device evolves Support internal audits and manage relationships with external quality consultants as needed Project Management (Majority initially; transitions to minority over time) Establish and maintain the single integrated project schedule ("schedule of truth") across engineering, clinical, quality, and regulatory teams Run recurring milestone meetings, ensuring dependencies, risks, and timelines are clear and aligned Coordinate cross-functional execution, driving follow-through, documentation readiness, and timely decision-making Interface with Jira (reading tickets, understanding software timelines, logging issues) and integrate software progress into broader project planning Apply structured PM methodologies (Six Sigma, Lean, PMP, or similar) to improve visibility, reduce slippage, and increase operational consistency What You BringRequired Qualifications 5+ years of experience in medical devices, including 3+ years directly in Quality Engineering Direct experience with ISO 13485-aligned QMS implementation, ownership, or maintenance Ability to understand, interpret, and apply FDA regulations and relevant recognized standards, including: IEC 62304 - medical device software lifecycle processes IEC 62366-1 - usability engineering Experience supporting products through prototype product development regulatory readiness Strong documentation, communication, and cross-functional coordination skills Demonstrated ability to thrive in fast-moving, ambiguous early-stage environments Preferred Qualifications Experience migrating or configuring medical-grade eQMS platforms (e.g., Greenlight, Enzyme, Qualio, MasterControl) Familiarity with robotics, embedded systems, or software-heavy medical devices Experience with Jira, MS Project, Smartsheet, or similar tools Six Sigma Green Belt or Black Belt, PMP, or equivalent PM certification Prior startup or small-team engineering experience Who You Are A builder who enjoys creating systems, structure, and process from the ground up Equally comfortable with big-picture planning and detailed execution A low-ego contributor who thrives in small, high-collaboration environments Adaptable, curious, and energized by solving meaningful, messy problems Motivated by mission-driven work and excited to bring a novel medical device to market Work Environment & Benefits Onsite required at the Dublin, OH facility, Hybrid may be considered for local candidates (2-3 days onsite weekly minimum) Equity: Stock options Benefits: Medical, dental, vision, flexible PTO, paid holidays, winter shutdown Relocation support available for candidates moving to the Columbus/Dublin region

Created: 2026-03-04